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ORIGINAL REPORT
Fary Khan, MBBS, MD, FAFRM (RACP)1,2,3, Bhasker Amatya, MD, MPH1, Kate Drummond
MBBS, MD, FRACS3,4 and Mary Galea, PhD, BAppSci (Physio), BA, Grad Dip Physio, Grad
Dip Neurosci1,3
From the 1Department of Rehabilitation Medicine, Royal Melbourne Hospital, 2School of Public Health and Preventive
Medicine, Monash University, 3Department of Medicine (Royal Melbourne Hospital), The University of Melbourne and
4
Department of Neuroscience, Royal Melbourne Hospital, Parkville, Victoria, Australia
work, financial constraints, marital stress and general limitation participants resided in the community (area of greater Melbourne <60
in patients participation. km radius), and were able to communicate in English. Those who
had benign or metastatic BTs, significant co-morbidities or medically
BT is a complex and challenging condition requiring inte-
unstable, or psychiatric disorders (such as uncontrolled schizophrenia,
grated multidisciplinary care and services. The UK National actively suicidal/self-harm or physically aggressive (based on clinical
Service Framework for Long-Term Neurological conditions judgement)) limiting participation in rehabilitation, those bed-bound
(12) (including BT), advocates 11 Quality-Requirements and/or institutionalized in nursing homes were excluded.
for integrated, life-long, person-centred care, and provides The study was approved by the Royal Melbourne Hospital Ethical
Committee (No. 2010.216) and informed consent was obtained from
guidelines to explore the interaction between neurology, all the subjects.
rehabilitation and palliative care services (neuropalliative-
rehabilitation), in hospital and community. Needs must be Procedure
defined so services can be matched for these individuals to Group allocation. All eligible patients (n=152) based on selection
optimise care. However, no studies currently utilize this pro- criteria were contacted by mail and invited to participate in this
posed model of care in the BT population. project by an independent project officer. A total of 106 subjects who
consented were recruited for the study (Fig. 1). Consistent with usual
Although several studies evaluate functional outcomes for
care procedures, all patients were mailed an information package
BT survivors from a multidisciplinary rehabilitation (MDR) (containing standard BT education, information and support services
perspective (7, 1321), many are methodologically flawed details). After written informed consent, all participants were assessed
(bias, lack of control group and blinding). A recent system- and baseline data was obtained in a subacute clinical settings. All
atic review of MDR for BT (22) identified no randomized or patients were allocated either to the treatment or control group by
the treating team based on their clinical need. Attempts were made to
controlled clinical trial (RCT/CCT) in this area. However,
ensure equal distribution of more aggressive BTs (based on histology)
10 observational studies of poor methodological quality in each group. The treatment group (n=53) received an individualized
provided weak evidence for short-term gains for impair- intensive ambulatory (centre-based) MDR, while the waitlist patients
ment, psychosocial adjustment and QoL. No studies explored were the control group (n=53), who continued with their usual activ-
participation (social reintegration, return to driving, work) and ity in the community (see details below), monitored by their surgeon/
oncologist and/or family doctors. The control group were informed
none were in the Australian context. To date no clinical trials that it could take between 2 to 3 months before they received intensive
have evaluated effectiveness of MDR outcomes or comparisons rehabilitation, consistent with current practice.
of different methods of treatment in these persons. Therefore,
the aim of this study was to evaluate the effectiveness of MDR Assessment interviews. After group allocation all baseline assess-
ments and interviews were completed using a structured format, by
in persons after BT treatment in an Australian community 3 independent experienced trained researchers over a 6-week period.
cohort. The effectiveness of rehabilitation in these survivors These assessors (two physicians and a research officer) received a
was expected primarily in the activity domains and secondly 3-day training session in cognitive and functional ability assess-
in participation. ments examined and accredited by a national body (the Australian
Rehabilitation Outcomes Centre). They were not in contact with the
acute surgical/oncological or the treating rehabilitation teams. They
did not share information about participants or assessments, and re-
METHODS ceived separate and different clinical record forms at each interview.
Participants and setting The information obtained included: demographic and disease-related
This prospective CCT was part of rehabilitation research program for information, cognitive and functional ability assessment and health-
BT survivors (gliomas), conducted at the Royal Melbourne Hospital related QoL measures using standardized instruments (see measures).
(RMH), a tertiary referral centre in Victoria, Australia. The RMH MDR These interviews took approximately 40 min, with appropriate rest
program provides intensive individualized treatment for BT survivors breaks. The assessors did not prompt participants, but provided as-
both in ambulatory and inpatient settings. sistance for those who had difficulty completing the questionnaires.
The recruitment process has been reported previously (11, 23). A All participants were evaluated at recruitment and at 3 and 6 months
clinical quality improvement audit at RMH identified 862 consecutive after completion of their rehabilitation program by the same three
admissions for acute care between 20072011, with the International assessors. The assessors did not have access to previous assessments,
Classification Diseases (ICD) Code (C71) for BT (main diagnosis) treatment schedules or treating rehabilitation therapy team documenta-
incorporating all 10 sub-codes (C71.071.9) (excludes cranial nerves). tion. Participants were instructed to make no comments on whatever
These included same and multiday patients and those with recurrent treatment they received in the time interval between examinations and
admissions (details available from authors). The RMH Database was only to report any concurrent illness or hospitalization. The control
used for cross-indexing of diseases from HOMER using the Patient group was monitored in the community as per usual by their treating
Administrator System of the Hospital Information Systems. The general practitioners/oncologists/surgeons. All assessments were se-
source of these patients was a pool of persons residing in the com- cured and filed, and opened only at the time of entry into the database
munity, referred to the RMH from public and private medical clinics by an independent data entry officer.
across greater Melbourne in Victoria. All patients were aged 18 years
and over and fulfilled criteria for BT grading system (Grade IIV) Treatment schedules
for gliomas as outlined by the WHO for Central Nervous System Participants in the treatment group received comprehensive indi-
Tumours (24); and assessed by a surgeon/oncologist. The inclusion vidualized MDR (for up to 68 weeks) over the study period. An
criteria for intensive MDR included: stable medical course, post BT assessment of each patients potential to benefit from MDR program
surgery, radiotherapy and/or chemotherapy, assessed by a rehabilita- was based on clinical features, individual need and accessibility to
tion physician/neurosurgeon for presence of neurological deficits and services, and made by a treating therapy team, who were not aware
ability to participate in therapy up to 2.5 h of interrupted therapy/day; of the allocation of patients in the trial. They assessed these patients
and the clinical judgment of the assessing rehabilitation team. These along with the usual referrals from the community referred by general
J Rehabil Med 46
756 F. Khan et al.
practitioners, community health centres and other hospitals (general, Perceived Impact of Problem Profile (PIPP) (28), a 23-item scale
surgical and oncology units) for a range of disabilities, consistent with 5 subscales: Mobility, Self-care, Relationships, Participation and
with current practice. Psychological Well-being, assessed the impact associated with BT. For
The MDR program included intensive treatment beyond symp- each item, respondents were asked to rate how much impact has your
tomatic management of BT, which was individualized, achievable, current health problems had on (item of function or activity), using
time-based, functional, and goal-oriented with active involvement of a 6-point scale (no impact and extreme impact), with high scores
patient (and family). The MDR incorporated a wide range of elements, indicating greater impact.
such as education and health promotion for those mildly affected, to
intensive mobilization and task reacquisition programs for the more Statistical analysis
severely affected patients. Consistent with existing practice at the The FIM (motor) was the primary outcome for this study. The study
RMH, MDR comprised half-hour blocks of therapy sessions (Social, was powered with 36 patients in each group needed for a 80% chance
Psychology, Occupational Therapy and Physiotherapy), 2 to 3 times to detect a 3-point difference in FIM from baseline to 6 months in
per week for up to 8 weeks. A priori compliance with treatment was intervention versus control groups, assuming similar standard devia-
defined as participant attendance in >80% of treatment sessions. tion (SD) change of 8.5 in both groups (two-sided alpha=0.05). The
Rehabilitation assessments for the treatment group were completed primary analyses were conducted using analysis of covariance (AN-
within one week of admission to the program. Structured weekly team COVA), comparing the post-treatment scores (3 and 6 months follow-
case conferences assessed patient progress and goal setting. Adverse up) for the control and treatment groups, with the baseline score as a
effects of rehabilitation were noted (falls, injury during treatment). covariate. Mann-Whitney U tests compared change scores on each of
the outcome measures (FIM, CARES-SF, DASS and PIPP) (baseline
Measurement minus first and second post-treatment follow-up) for the treatment
The ICF (8) was used as a conceptual basis for choice of best outcomes and control groups. Effect size statistics (r) were calculated and as-
for measurement. sessed against Cohens criteria (0.1=small, 0.3=medium, 0.5=large
effect) (29). Additional analyses were conducted comparing change
BT-related information. This included: socio-demographic data, co- scores on all measures. A p-value of <0.05 was considered statistically
morbid conditions (diabetes, ischemic heart disease), presence of significant. Analyses were on an intention-to-treat (ITT) basis, with
dysphasia; and BT lesion size, type, tumour grade and localization; patients assigned according to their initial allocation irrespective of
and treatments received. their subsequent compliance to the protocol.
J Rehabil Med 46
Effectiveness of multidisciplinary rehabilitation in brain tumour 757
J Rehabil Med 46
758 F. Khan et al.
Longer-term subjective outcomes. At 6 months follow-up, similar to those in other studies with respect to demographic
compared to the control group, statistically significant im- and clinical characteristics (1315, 18, 32). The rehabilitation
provement in the treatment group was maintained for the FIM program provided standard treatment and management in ac-
sphincter (p<0.01, r=0.4) and communication (p<0.01, cordance with existing BT care guidelines (33, 34).
r=0.5) subscales; and psychosocial and cognition (p<0.01 It is not surprising that targeted MDR in BT survivors im-
for both), compared to control group. No difference between proved activity (self-care, mobility, continence) in the shorter-
groups was noted in other subscales (Table II). term (3 months) as they benefit from intensive reconditioning,
exercise and task re-acquisition strategies. Many also showed
improvement in psychosocial interactions, communication
DISCUSSION
and cognitive abilities (problem solving, memory), with gains
To our knowledge this is the first clinical trial evaluating efficacy maintained at 6 months follow-up. This may be due to cessation
of an ambulatory MDR program for BT population (gliomas) of radio/chemotherapy regimens for those with more aggres-
following definitive treatment in an Australian community sive tumour types and improved fitness through structured
cohort. The participants were with established impairments and specific interventions within the MDR program. Partici-
and functional disability, with median time since diagnosis pants in this study were complex in terms of disease severity,
of 2 years. These results provide some support for MDR for symptoms and co-morbidities (reflective of clinical practice)
functional gain and psychosocial adjustment after BT treatment, and presented with a range of survivorship issues, which
consistent with other reports (6, 1316, 18, 30, 31). The treat- required an individualized approach. Standardizing therapy
ment group compared with the control group, showed improved was difficult, therefore individualization of treatments was
activity at 3 months following MDR and psychosocial gains used (i.e., a described intervention provided by therapist X,
were maintained at 6-month follow-up. There were no changes e.g., a 30-min treatment session included a stretching and
in other outcome measures (DASS, PIPP and CARES-SF Global muscle strengthening protocol) (35). However, determining
scores) at both time-points. The participants in this study were the effective dose, intensity, components and combination of
J Rehabil Med 46
Effectiveness of multidisciplinary rehabilitation in brain tumour 759
treatment modalities in rehabilitation in the study population were contacted, irrespective of their demographic or disease
was not possible, and further research is needed. status, and the study cohort covered a wide geographical popula-
With improved BT survival rates there is a growing acceptance tion in Victoria representing a wider sample of BT survivors in
of the longer-term factors impacting psychological functioning the community. Comparison and generalisability of these results
and QoL, however, these are often under-estimated (36, 37). is difficult, larger sample sizes in different settings are needed
Participants in this study did not show improvement in outcome to confirm these findings. There was no statistical difference in
measures assessing participation and QoL. This is not surpris- any of the study variables between participants who completed
ing as QoL is a difficult concept to measure, as many factors post-treatment assessment and those lost to follow-up. We
influence it. Survivorship issues (pain/headache, fatigue, low acknowledge that other factors may have impacted depression
mood, psychosocial needs, the physical effects of treatment and and QoL in BT participants and were not studied. More research
consequences) can influence coping with cancer, attainment of into ongoing pain and other outcomes is needed. To reduce po-
previous levels of functioning (36), and negatively influence tential bias the treating therapists and assessors were blinded.
QoL (37). The optimum assessment tools for participation in BT The assessors were independent of the rehabilitation or acute
are yet to be identified, and vary in different studies. Measures hospital teams. Important outcomes such as impact on carers and
such as CARES-SF, PIPP, DASS have ceiling effects, although families and analysis of costs associated with care were beyond
they show clinical change with treatment but low statistical the scope of this study. The impact of other different components
significance (ES). These issues have important implications for of MD rehabilitation modalities and interventions is unknown.
longer-term monitoring, education, health promotion, support This study highlighted challenges associated with conducting
and counselling of the BT patients (and their families) (22). research in the real world setting of a tertiary public hospital
Rehabilitation in BT survivors is challenging as they can with finite resources. It was difficult to recruit participants as
present with various combinations of disabilities (physical, many were still undergoing radio/chemotherapy post-surgery,
cognitive, psychosocial, behavioural and environmental) (3, the mortality rates for aggressive BTs was high, and transport
9). The ICF (8) provides a useful framework for describing was an issue for those residing further away from our facility.
the impact of disease at the level of limitation in activity and There were no patient referral protocols for treating medical/
participation. Our initial study (n=106) (23) highlighted the surgical staff for an integrated neuro-rehabilitative-palliative
patient-perspective of functional limitations due to BT, using approach (40). This required education of various treating teams
the ICF domains and linkage with ICF categories for relevant and integration of existing services that operated in silos, with
issues following definitive treatment. Participants identified fragmented service delivery. The control group were informed
many relevant ICF categories (88%), indicating a range of of the wait time for rehabilitation services as per usual practice,
potential problems in: mobility, domestic life, inter-personal, and were not unduly disadvantaged. Operationally, it was beyond
family and intimate relations, and major life areas (economic the resources of our hospital to provide therapy for this many
self-sufficiency, remunerative employment). The most fre- patients simultaneously. Rehabilitation is an expensive interven-
quent issues identified (driving, recreation, and remunerative tion. The implications of this study include triaging and prior-
employment), reflected the socio-demographic characteristics itizing the BT survivor who needs targeted rehabilitation input.
and age distribution of participants (working age, educated, Rehabilitation for BT survivors is challenging due to high
living with family) (23). Further, at 2 years following definitive mortality rates. The condition is often progressive in nature,
treatment, these BT participants (n=106) (11) showed that, with an uncertain prognosis, and multifaceted physical, psycho-
despite good functional recovery over one-half reported pain logical and cognitive disabilities, and participatory limitations
(mainly headache), followed by impairments such as ataxia that require an integrated interdisciplinary approach (4). This
(44%), seizures (43%); paresis (37%), cognitive dysfunction study provides some evidence to support MDR for improved
(36%) and visual impairment (35%). This study also found that activity in BT survivors in the shorter-term. More research in
about 20% reported high levels of depression compared with the effectiveness of specific rehabilitation interventions and
only 13% in an Australian normative sample (11). Emphasis participation domains is needed. The MDR for BT survivors
should be on a longer-term monitoring of maintenance of func- should be considered by treating clinical teams to improve dis-
tion and psychological sequelae in the community. ability management. Further, emphasis on outcome-orientated
There were many challenges in conducting a clinical trial in research to explore service models and strategies to implement
a rehabilitation setting, similar to other reports (38, 39). This individualized treatment and integrated MDR programs is
study has some potential limitations. First, randomisation of needed to address survivorship issues in BT.
the participants was not possible due to ethical considerations;
methodological issues included heterogeneous patient charac-
teristics, multilayered treatments, interdependent components ACKNOWLEDGEMENT
and individual interventions. Second, selection bias cannot be We are grateful to all participants with primary brain tumour in this study.
ruled out as participants are a selective cohort listed on a single We thank Ms L Oscari, Dr K Mackenzie and Dr I Rajapaksa for patient
database held at single tertiary institution (RMH) who agreed to assessments; Dr L Ng for assistance with ethics submission and T Khan
participate in research projects. This may limit generalizability for data entry.
of findings. However, all eligible participants on the database The authors declare no conflicts of interest.
J Rehabil Med 46
760 F. Khan et al.
J Rehabil Med 46